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| ID | Type | Description | Link |
|---|---|---|---|
| R21HL162572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Children with Down syndrome (DS) often experience dangerously low heart rates on induction of anesthesia for routine procedures and this occurs at 10 times the rate of non-DS patients. Given that the cardiac output of children is heart rate dependent, bradycardia is especially perilous in this population.
Historically, individuals with DS were not expected to survive beyond childhood; consequently, correction of congenital anomalies, e.g. cardiac defects, was not frequently offered. Fortunately, today individuals with DS live into adulthood and surgical correction of anomalies is universally offered. Thus, increasing numbers of children with DS are exposed to anesthesia and at risk for this hemodynamic catastrophe. It is medically unacceptable and an autonomic nervous system mechanism will be sought.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Down Syndrome patients undergoing otolaryngologic surgery with anesthesia |
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| Non-Down Syndrome patients undergoing otolaryngologic surgery with anesthesia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia | Other | Use of an Ambulatory Monitoring System from Vuije University (VU-AMS) to record autonomic and cardiovascular activity of patients undergoing otolaryngologic surgery with anesthesia. This monitoring device will provide data of ANS activity and normoxic bradycardia among patients with Down Syndrome. This data will be compared to data from patients without Down Syndrome. |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory feasibility of VU-AMS monitor on patients with Down Syndrome | Subjects will be observed for monitor use coming to the hospital for surgery. The two outcomes will be binary: wearing the device or not. We anticipate that 50% of subjects will be wearing the VU-AMS monitor on entry to the hospital on the day of surgery. | Immediately upon entry into Same Day Surgery patient room |
| Ambulatory feasibility of VU-AMS monitor on patients without Down Syndrome | Subjects will be observed for monitor use coming to the hospital for surgery. The two outcomes will be binary: wearing the device or not. We anticipate that 50% of subjects will be wearing the VU-AMS monitor on entry to the hospital on the day of surgery. | Immediately upon entry into Same Day Surgery patient room |
| Operating room feasibility of VU-AMS monitor on patients with Down Syndrome | Subjects will be observed for monitor use throughout surgery. We anticipate that 80% of subjects will wear the VU-AMS in the operating room | Immediately prior to mask induction with sevoflurane |
| Operating room feasibility of VU-AMS monitor on patients without Down Syndrome | Subjects will be observed for monitor use throughout surgery. We anticipate that 80% of subjects will wear the VU-AMS in the operating room | Immediately prior to mask induction with sevoflurane |
| Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients with Down Syndrome | Among subjects who become bradycardic with induction of anesthesia, we expect that the pre-ejection period will increase by 20% | Beginning at time of bradycardia and continuing for the next 300 seconds. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be children age 1 month to 8 years undergoing otolaryngologic surgery with anesthesia.
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Sinton | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 15, 2024 | |
| Reset | Dec 9, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 15, 2024 | Dec 9, 2024 |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients without Down Syndrome | Among subjects who become bradycardic with induction of anesthesia, we expect that the pre-ejection period will increase by 20% | Beginning at time of bradycardia and continuing for the next 300 seconds. |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |